Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Non-Obese/0 kcal | Non-obese participants that received no snack food to consume for two weeks. | None | None | 0 | 10 | 0 | 10 | View |
| Non-Obese/100 kcal | Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks. | None | None | 0 | 11 | 0 | 11 | View |
| Non-obese/300 kcal | Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks. | None | None | 0 | 10 | 0 | 10 | View |
| Obese/0 kcal | Obese participants that received no food to consume for two weeks. | None | None | 0 | 11 | 0 | 11 | View |
| Obese/100 kcal | Obese participants that received a 100 kcal portion of food to consume daily for two weeks. | None | None | 0 | 12 | 0 | 12 | View |
| Obese/300 kcal | Obese individuals who received a 300 kcal portion of food to consume for 2 weeks. | None | None | 0 | 11 | 0 | 11 | View |